Skip to Main Content

The University of Tennessee

The Graduate School of Medicine



Research » The Institutional Review Board » Standard Operating Procedures


Standard Operating Procedures

In an effort to foster research integrity and safety the Institutional Review Board of the University of Tennessee Graduate School of Medicine hereby establishes the following policies and procedures.  These policies and procedures will be interpreted and enforced in accordance with the principles outlined in the Belmont Report , Federal and State laws, rules and regulations, general principles of Medical Ethics, and applicable policies and procedures of the University of Tennessee.

Number

Title

001

IRB Authority, Membership and Permanent Positions

002

IRB Member Education

003

Review of Research

004

Criteria for Approval

005

Informed Consent

006

Informed Consent – Non-English Speaking Subjects

007

Emergency Exemption from Informed Consent

008

Confidentiality - Anonymity

009

HIPAA Authorization For use of PHI

010

HIPAA Use of PHI Without Authorization

011

Additional Protections-Pregnant Women, Neonates and Fetuses

012

Additional Protections- Prisoners

013

Additional Protections- Children and Minors

014

Exempt Applications

015

Expedited Review

016

Continuing Review

017

Serious Advent Event Reporting

018

Review of Safety Alerts

019

Protocol Deviation Reporting

020

Review of Advertisements

021

Conflict of Interest

022

Significant Risk / Non-Significant Risk Determinations

023

Emergency Use

024

Compassionate Use

025

Humanitarian Use Devices

026

Certificates of Confidentiality

027

Responsibilities of Investigators

028

Appeal of IRB Decisions / Request for Re-Review

029

Investigator Non-Compliance

030

Audits of Investigators/Sites

031

Communication From the IRB

 

Appendix 1

The Belmont Report

Appendix 2

HHS Regulations

Appendix 3

FDA Regulations

Appendix 4

IRB Confidentiality Agreement

Appendix 5

Genetic Materials Consent Template

Appendix 6

Specimen Repository Consent Template

The University of Tennessee Graduate School of Medicine

The Institutional Review Board
1924 Alcoa Highway
Knoxville, TN 37920
Phone: (865) -305-9781
Fax: (865) 305-9275